European Commission clears Novartis Rasilez-based triple combination pill

29th November 2011 (Last Updated November 29th, 2011 18:30)

The European Commission has approved Novartis Pharmaceuticals' Rasitrio, a Rasilez-based triple combination pill of aliskiren, amlodipine and hydrochlorothiazide that is used as a substitution therapy for patients with high blood pressure.

Novartis

The European Commission has approved Novartis Pharmaceuticals' Rasitrio, a Rasilez-based triple combination pill of aliskiren, amlodipine and hydrochlorothiazide that is used as a substitution therapy for patients with high blood pressure.

Rasitrio integrates direct renin inhibitor, Rasilez, with calcium channel blocker amlodipine and the diuretic hydrochlorothiazide, and acts by targeting renin for optimal control of the renin angiotensin aldosterone system, which is a key regulator of high blood pressure.

The Rasilez component of the Rasitrio pill binds to and inhibits renin to reduce blood pressure.

Calcium channel blocker amlodipine lowers blood pressure by relaxing the blood vessel walls, while diuretic hydrochlorothiazide increases the excretion of sodium chloride and water to lower blood pressure.

Novartis Pharmaceuticals Division Head David Epstein said that Rasitrio is the first Rasilez-based triple combination pill available in Europe to help patients requiring multiple medications reach their treatment goal.

"For the first time, high-blood pressure patients in Europe with complex needs will have access to a single pill combining the unique properties of Rasilez with two well-established and effective high blood pressure treatments," Epstein added.

The approval of Rasitrio is supported by pivotal Phase III data including more than 1,181 patients with high blood pressure.

The study demonstrated that Rasitrio produced a considerable reduction in blood pressure compared to dual combinations of each of its individual components, including aliskiren/amlodipine 300mg/10mg, aliskiren/ hydrochlorothiazide 300mg/25 mg and amlodipine/ hydrochlorothiazide 10mg/25mg.

In the trial, the effect of Rasitrio was seen as early as one week following initiation of therapy and was sustained over the entire 24-hour dose interval.

Rasilez is approved in more than 80 countries, while aliskiren is approved in the US and in the European Union.

Tekturna HCT, a single pill combination of aliskiren and hydrochlorothiazide is approved in the US for first-line and second-line treatment of high blood pressure.